Kornimate/medical-research-clean huggingface dataset:
the impact of artemether-lumefantrine on genes associated with antimalarial resistance

Conditions: Falciparum Malaria; Antimalarials

Summary: the newly introduced antimalarial drug artemether-lumefantrine is currently recommended as second line antimalarial in sudan. recurrent infection after treatment with this drug has been associated with selection of certain genes in the malaria parasite. however there is no information on this association in sudan.this study is going to look into the genetics of resistance to artemether-lumefantrine.

in sudan the current treatment protocol includes two artemisinin combinations (act); artesunate + sulphadoxine/pyrimethamine (as/sp) as first line and artemether-lumefantrine (al) as second line. this protocol has been implemented in 2004, since then various studies have reported the high efficacy of both combinations (e.g. adam et al., 2005; elamin et al., 2005; mohamed et al., 2006). however, there has been no report of the impact of these combinations on drug resistance markers in sudan. data from other african countries has shown that al selects for certain alleles in the pfmdr-1 gene (sisowath et al., 2005, dokomajilar et al., 2006; humphreys et al., 2007), but the impact on the prevalence of different pfcrt and pfmdr-1alleles remains unclear. it is essential to monitor act efficacy in addition to identify molecular markers that are associated with response to different drugs to facilitate epidemiological surveys for evidence based decision making. recent work in the gambia suggests that transmission-related endpoints, such as emergence of gametocytes after treatment, may be better indicators of emerging drug resistance (hallett et al., 2006). the aim of the proposed study is to examine the impact of treatment with artemether-lumefantrine (al) on alleles of pfcrt and pfmdr-1 in p. falciparum isolates in an area of marked seasonal transmission in eastern sudan. most studies of resistance markers measure marker prevalence by dna amplification, but we will also investigate gene expression using quantitative amplification of mrna encoding pfcrt and pfmdr-1. the impact of genotype and gene expression levels on treatment outcome, and on the emergence and density of peripheral gametocytes will be examined.

Eligibility criteria:
inclusion criteria: * mono-infection with p. falciparum by microscopy. * initial parasite density of 1000 to 100,000 asexual parasites/µl. * absence of general danger signs or other signs of severe and complicated falciparum malaria according to who definitions. * informed consent provided by patient or parent/guardian. exclusion criteria: * pregnancy * infection with mixed plasmodium sp. * signs of severe malaria or any danger signs * refusal to provide consent

Keywords: artemether-lumefantrine plasmodium falciparum drug resistance genes
a study to assess the efficacy and safety of mnk-1411 in duchenne muscular dystrophy

Conditions: Muscular Dystrophy, Duchenne

Summary: this is a multicenter, double blind, placebo controlled, multiple dose study to examine the safety and efficacy of mnk-1411 in male subjects 4 to 8 years of age (inclusive) with duchenne muscular dystrophy (dmd).

the main purpose of this study is to determine the effect of mnk-1411 on motor function in participants with duchenne muscular dystrophy (dmd). information is collected only from caretakers who are fluent in english, using the pediatric outcomes data collection instrument (podci). the podci is a validated 86-question instrument completed by the parent or legal guardian of children 2 to 10 years of age to assess a variety of health outcome measures (uzark et al, 2012). this study will only collect information for the podci domains of sports and physical functioning and transfer/basic mobility.

Eligibility criteria:
inclusion criteria: 1. participants must have a documented diagnosis of duchenne muscular dystrophy (dmd) confirmed by complete dystrophin deficiency (by immunofluorescence and/or immunoblot), or identifiable mutation in the dmd gene where reading frame can be predicated as "out of frame," or complete dystrophin gene sequencing consistent with dmd; and in the opinion of the investigator, a typical clinical profile consistent with dmd. 2. participants taking approved treatments for dmd (by a health authority) that target dystrophin gene mutations (e.g., eteplirsen or ataluren) may be enrolled in the study if they have been on a stable dose for 30 days prior to the first dose of study drug, and plan to remain on that dose throughout the study. exclusion criteria: 1. participant has had previous systemic treatment with corticosteroids within 2 months prior to the screening visit. exception: in subjects who were down-titrated to a physiological dose of corticosteroids (ie, 3mg/m2 of prednisone or deflazacort) a maximum of 1 month of no greater than a physiological dose followed by 1 month completely off corticosteroids prior to the screening visit will be acceptable for study entry. transient previous use of corticosteroids will be evaluated on a case-by-case basis by the sponsor or designee. the use of topical or intra-articular corticosteroids is permitted during the study 2. participant is unable to complete the 10 meter walk/run test at the screening and/or baseline visit. 3. participant has type 1 or type 2 diabetes mellitus. 4. participant has a history of chronic active hepatitis including acute or chronic hepatitis b, or acute or chronic hepatitis c. 5. participant has a history of tuberculosis (tb) infection, any signs/symptoms of tb, or any close contact with an individual with an active tb infection. 6. participant has known immune compromised status (not related to disease/condition under study), including but not limited to, individuals who have undergone organ transplantation or who are known to be positive for the human immunodeficiency virus.

Keywords: muscular dystrophy dmd duchenne
study evaluating the efficacy and safety of sbi-087 in seropositive subjects with active rheumatoid arthritis

Conditions: Active Rheumatoid Arthritis

Summary: this study is designed to evaluate the safety and efficacy of a dose and dosage regimen of sbi-087 in seropositive patients with active rheumatoid arthritis, who are on a stable dose of methotrexate.


Eligibility criteria:
inclusion criteria: * meets the american college of rheumatology (acr) 1987 revised criteria for classification of rheumatoid arthritis (ra) for at least 6 months prior to screening * active ra as defined by \>= 5 swollen and \>= 5 tender joints (28-joint count) and at least 1 of the following: c-reactive protein \>= 10 mg/l or erythrocyte sedimentation rate \>= 28 mm/h * must be seropositive as defined by a documented history of rheumatoid factor (rf) or anti-cyclic citrullinated peptide (anti-ccp) positivity * must be receiving a stable route and dose of methotrexate (up to 25 mg weekly) exclusion criteria: * any significant health problem other than rheumatoid arthritis * any clinically significant laboratory abnormalities * any prior use of b cell-depleting therapy

Keywords: rheumatoid arthritis seropositive methotrexate
supporting resilience among re-entered seniors

Conditions: Chronic Disease

Summary: the first goal (aim 1) of this clinical trial is to learn about specific strengths, challenges, and desired areas of knowledge and skill-building among older adults who re-entered their communities from a period of incarceration and to then develop a new psychoeducational intervention tailored to these older adults. the second goal (aim 2) of this clinical trial is to test if the intervention increases chronic disease management and whether the intervention is considered appropriate and acceptable by older adults who re-entered their communities from a period of incarceration. aim 1 participants will: * complete a baseline survey * participate in a focus group aim 2 participants will: * complete a baseline survey * participate in an 8-week once weekly intervention * complete three follow up surveys

the protocol for aim 2 will be developed once the focus group data is analyzed.

Eligibility criteria:
inclusion criteria: * at least 45 years old * have re-entered the community from a period of incarceration from jail or prison * have at least one chronic health condition * able to speak and understand english exclusion criteria: * aged 44 or younger * have not re-entered the community from a period of incarceration from jail or prison * does not have at least one chronic health condition * unable to speak and understand english
study of the response and cardiorespiratory endurance in early ra patients treated with tocilizumab or methotrexate

Conditions: Rheumatoid Arthritis

Summary: to measure the cre by a work capacity index obtained in a submaximal testing (w65%/kg) in early ra patients treated with tocilizumab compared to methotrexate alone. the secondary endpoints : analyze the clinical efficacy of tocilizumab in this population and correlate the cre response with other marker (crp, hb, das, haq) and evaluate the safety profile of tocilizumab.

rheumatoid arthritis (ra) is the most prevalent (about 1%) inflammatory rheumatic disorder. interleukin-6 (il-6) has emerged as a potential therapeutic target in ra. this is based on the greater understanding of the role this cytokine can play in various aspects of the pathogenesis of ra. it has been shown that il-6 is responsible for various clinical symptoms, including,fatigue, anemia, anorexia, fever, as well as the production of autoantibodies and increase in the erythrocyte sedimentation rate, all of which develop in patients with ra. tocilizumab, as monotherapy and in combination with methotrexate, has been shown to be effective for ra patients with insufficient response to methotrexate or other disease-modifying antirheumatic drugs. these observations about the effects of tocilizumab were extended to patients refractory to tumor necrosis factor inhibitors. tocilizumab also slows down the progression of structural joint damage. furthermore, a 5-year long-term safety and efficacy has been shown. the place of tocilizumab therapy in early ra is still unknown. cardiorespiratory endurance (cre), the most fundamental component of physical fitness can be severely impaired in patients with rheumatoid arthritis (ra). it has been shown that intensive and early treatment of ra can induce sustained clinical remission, improve general health and physical fitness and might therefore have an impact on the quality of life of ra patient. this study was planned to measure the cre by a work capacity index obtained in a submaximal testing (w65%/kg) in early ra patients treated with tocilizumab compared to methotrexate alone.

Eligibility criteria:
inclusion criteria: * diagnosis of ra (according to american college of rheumatology acr criteria) * disease duration \< 2 years. * age between 18 and 70 years old. * active ra defined by a disease activity score 28 das28-crp score \> 3.2 with a swollen joint count ≥ 4 * mtx naive * stable therapy with corticosteroids or nonsteroidal anti-inflammatory drug nsaids * presence of knee arthralgia or synovitis (addendum protocol with synovial biopsy). exclusion criteria: previous mtx treatment. exclusion for severe physical handicap to perform cre. exclusion for general safety (history of severe allergic reaction, sepsis, malignancy within 5 years, pregnancy, severe heart failure) concurrent treatment with other dmards than mtx or any anti-tnf and biological therapies.

Keywords: rheumatoid arthritis tocilizumab cardiorespiratory endurance
study to evaluate the improvement effect on subjective symptom of fexuclue tab

Conditions: Gastroesophageal Reflux Disease

Summary: this observational study is a large-scale, prospective, and multi-institutional observational study. patients from 19 to 75 years of age, will take a self-assessment (pro) during the study period before and after administration of pexuclue tablet.

data will be collected based on patient's medical records from daily visit. enrolled subjects will take a patient reported outcome (pro) survey including quality of life evaluation (gerd-hrql) and self-awareness symptom (rdq). the survey will be done twice (before and after the administration of fexuclue tablet) electronically through an application (e-pro).

Eligibility criteria:
inclusion criteria: 1. adult aged 19 years to 75 years (on registration date) 2. patient scheduled to administer fexuclue tablet based on the medical judgment of investigator. 3. patient who agreed to participate in this observation study and signed informed consent form exclusion criteria: 1. a person who falls under the prohibition of administration according to the permission for fexuclue tablet * patients with hypersensitivity to the components of fexuclue tablet or fexuclue tablet and a history thereof * patients undergoing atazanavir, nelfinavir or lilpivirin-containing preparations * pregnant and lactating women * patients with genetic problems such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabortion 2. a person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices; 3. in addition to the above, a person who has determined that the researcher (the doctor in charge) is not suitable for participation in this observation study
amg 176 with azacitidine in subjects with myelodysplastic syndrome /chronic myelomonocytic leukemia

Conditions: Higher Risk Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia

Summary: the main objective is to assess the safety, tolerability, and efficacy of amg 176 as monotherapy and in combination with the 7-day regimen of azacitidine for the treatment of higher-risk myelodysplastic syndrome and chronic myelomonocytic leukemia (hr-mds/cmml).

this study is a phase 1 clinical trial designed to assess the safety, tolerability, and efficacy of amg 176 as monotherapy and in combination with the 7-day regimen of azacitidine for the treatment of hr-mds/cmml. participants will be treated with intravenous (iv) amg 176 and iv or subcutaneous (sc) azacitidine.

Eligibility criteria:
inclusion criteria: * age \>= 18 years of age * for part 1, participants have r/r mds post-hma failure, defined as prior receipt of 4 cycles of hma therapy (including but not limited to decitabine, azacitidine, investigational hmas such as sgi-110, and oral hmas such as oral decitabine and cedazuridine \[astx727\] and oral azacitidine \[cc-486\]) with failure to attain a response or progression of disease or relapse at any time after prior response to hma therapy a. note: participants with hr-cmml (cmml-1 or 2 by world health organization \[who\]) are eligible. hydroxyurea administration will be allowed on the study to lower the white cell count to \<= 10 000/μl prior to the initiation of therapy * for part 2, participants will be divided into 2 cohorts: 1. hma failure cohort: participants with r/r mds post-hma failure. participants who have previously received venetoclax are eligible and will be stratified accordingly in the hma failure cohort; 2. newly diagnosed cohort: participants with treatment-naïve newly diagnosed hr-mds (revised international prognostic scoring system \[ipss-r\] score \>3.5) are eligible for enrollment only after all prior cohorts have been completed. hydroxyurea administration will be allowed on the study to lower the white cell count to \<= 10 000/μl prior to the initiation of therapy. participants with hr-cmml (cmml-1 or 2 by who) are eligible exclusion criteria: * participants with newly diagnosed mds with revised international prognostic scoring system (ipss-r) lower-risk category (ipss-r score \< 3.5) * participants with cmml-0 by who * history of other malignancy within the past 2 years prior to enrollment (with some exceptions as listed in full list of criteria) * excluded prior and/or concomitant therapies as listed in the full list of criteria * participants who are fit and deemed eligible by the investigator for intensive salvage therapy

Keywords: higher risk myelodysplastic syndrome chronic myelomonocytic leukemia myelodysplastic syndrome myelomonocytic leukemia
medico-economic evaluation of management strategies for severe epistaxis

Conditions: Epistaxis

Summary: current recommendations consider surgical ligation and supra-selective embolization as equivalent in terms of efficacy and there is no clear consensus to choose between one and the other technique. in the absence of medico-economic studies, these recommendations could not be based on any differences in efficiency between the two techniques. the management of patients with severe non-traumatic epistaxis remains controversial and varies according to the hospital and/or university centers. in practice, the use of one or the other technique depends on the habits of each reference center.

the hypothesis is that early ligation of the sphenopalatine arteries would reduce the costs of care for the community while improving the quality of life of patients compared to supra-elective embolization. this medico-economic superiority could go through: * reduction in the number of recurrences * reduction in the length of hospital stays. * reduction in the cost of postoperative care. * reduction of iatrogenic complications * improvement of functional suites upon return home. * tertiary prevention of dependency, particularly among the elderly

Eligibility criteria:
inclusion criteria: * patient with severe epistaxis who failed treatment with double tamponade for more than 48 hours. * patient over 18 years old * affiliated patient or beneficiary of a social security scheme. * patient accepting the principle of randomization * free, informed and written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research). exclusion criteria: * patient with epistaxis secondary to facial and/or surgical trauma. * patient with epistaxis related to a malignant tumor cause * patient with a history of ligation or embolization * patient under legal protection and/or curatorship and/or guardianship. * impossibility of giving the person informed information and ensuring the subject's compliance due to impaired physical and/or psychological health. * patient participating in another research including an exclusion period still in progress * pregnant or breastfeeding patient for non randomized patient * patient with a contraindication to general anesthesia: severe and/or decompensated cardiac/hepatic/renal insufficiency, asa score 4 * severe hemostasis disorders that cannot benefit from correction. * history of transient and/or definitive stroke of the ischemic type * atheromatous overload

Keywords: severe epistaxis endoscopic ligation supra-selective embolization
tamsulosin as adjuvant treatment prior to endoscopic ureterolithotomy

Conditions: Ureterolithiasis; Ureteral Calculi; Urolithiasis

Summary: this a study aiming to compare treatment with tamsulosin versus placebo in patients undergoing endoscopic treatment for urolithiasis. the main outcome is the rate of stone free patients.

endoscopic treatment of urolithiasis has increased during the last several years. adrenergic receptors have been described mainly in the distal ureter. blockage of adrenergic receptors has been associated to a decrease in ureteral resistance. in this study the investigators hypothesized that alpha blockers are associated to a decrease in ureteral resistance with an increase in successful endoscopic management of urolithiasis. only patients with urolithiasis undergoing to endoscopic treatment are offered to participate. patients are randomized between placebo arm or tamsulosin 0.4 mg/day. demographic characteristics, stones characteristics and information related to surgery are recorded. main study outcome is stone free rate and successful insertion of semirigid ureteroscope 8,0 - 9,8 fr. all patients are follow-up for 30 days after surgery.

Eligibility criteria:
inclusion criteria: * patients with urolithiasis undergoing to endoscopic ureterolithotomy exclusion criteria: * patients with previous ureteral catheter * patients with allergy to tamsulosin * patients currently in treatment with tamsulosin for other disease different than ureterolithiasis * multiple ureterolithiasis * patients with impairment of their mental status * patients with open surgeries in the affected ureter or urinary diversion * pregnancy
betterbirth: a trial of the who safe childbirth checklist program

Conditions: Maternal Death; Maternal Morbidity; Stillbirth; Neonatal Death

Summary: the purpose of this study is to measure the impact of a checklist-based childbirth safety program (the who safe childbirth checklist program) on reduction of severe maternal, fetal, and newborn harm in institutional deliveries in north india.

the who safe childbirth checklist program is a quality improvement program designed to support health workers to deliver evidence-based practices to women and newborns around the time of institutional childbirths. at the program's core is the safe childbirth checklist, a 31-item list of essential practices that target the major causes of maternal and newborn mortality in low-resource settings globally. the program was developed over 3 years by a partnership of who and hsph, working with a large international network of experts and stakeholders in maternal, fetal, and newborn health. pilot testing of the program at a public-sector birth center in south india demonstrated dramatic improvements in health worker adherence to essential childbirth-related clinical care standards. the current study is a matched-pair, cluster randomized trial to measure the efficacy of the program in reducing severe maternal and newborn harm. this trial will be conducted at approximately 120 health facilities in uttar pradesh, india.

Eligibility criteria:
inclusion criteria: * for measuring outcomes, inclusion criteria are all mothers admitted to a study site for childbirth and newborn babies who are to be followed-up. in case a mother or baby from an enrolled site is referred out to another facility (before or after delivery) the mother-baby dyad will be included in the study and the outcome will be allocated to the referring facility * for a smaller subset of birth events (approximately 4,650 deliveries total), health worker practices will be observed to measure the impact of the scc program on delivery of essential practices, as a secondary outcome. a convenience sample of women who agree to observation and their babies cared for by the health workers around the time of childbirth at the facility during data collectors' duty hours will be included in this component of the study. exclusion criteria: * mothers who have been referred into the facility by an inter-facility transfer. * mothers being managed for abortion. * mothers who refuse consent for follow-up

Keywords: maternal health maternal death maternal morbidity stillbirth neonatal mortality quality improvement resource limited settings checklist safe childbirth